Whole-Body PET/CT Assessment of Tumor Perfusion Using Generator-Produced 62Cu

描述（由申请人提供）：本项目将评价一种使用发生器产生的铜-62评估肿瘤灌注的无创PET方法。所提出的方法将适合在美国的任何临床PET中心实施，补充目前的临床全身PET 18F-FDG研究，以评估肿瘤代谢。该项目的临床重点是头颈癌患者，文献证据表明肿瘤灌注测量可以预测对治疗的反应。接受同步放化疗的局部或局部晚期头颈癌患者将接受试验用62 Cu-ETS放射性药物进行“全身”PET/CT成像，以评估肿瘤灌注。62 Cu-ETS成像将在计划的标准基线和治疗后临床18 F-FDG PET/CT前即刻进行。还将使用15 O-水对一部分患者进行成像，以提供肿瘤灌注的独立参考测量。62 Cu-ETS肿瘤灌注结果将使用图像衍生动脉输入函数进行量化。肿瘤灌注的整体和区域测量将与18F-FDG成像的结果以及使用RECIST标准的肿瘤大小变化进行比较。受试者将在治疗完成后1个月接受随访;然后至少每3个月一次。将检查成像结果与临床结局独立指标的相关性，包括24个月精算局部无进展生存期、区域无进展生存期、无远处转移生存期和总生存期。治疗失败将定义为活检证实的复发性疾病，或影像学结果与疾病复发或转移以外的任何其他解释不一致。放化疗后计划的颈淋巴结清扫术显示存在残留的活肿瘤细胞，将不被归类为局部失败，因为这将被视为计划的治愈性治疗的完成。该项目需要并利用比例技术公司正在开发的放射性药物生产技术，以及来自普渡大学药学院和印第安纳州大学医学院的学术合作者的专业知识。公共卫生相关性：头颈部癌症约占美国成人恶性肿瘤的3%，并且不成比例地影响非洲裔美国人。该项目启动了PET成像方法的临床评估，以评估肿瘤血流，使用成像技术，可以很容易地在全国各地的医疗中心实施。这种PET方法有望提高医生为头颈癌患者做出最佳治疗决策的能力。

DESCRIPTION (provided by applicant): This project will evaluate a non-invasive PET method for assessment of tumor perfusion using generator- produced copper-62. The proposed method will be suitable for implementation at any clinical PET center in the U.S., complementing current clinical whole-body PET 18F-FDG studies to assess tumor metabolism. The project's clinical focus is patients with head-and-neck cancer, where literature evidence indicates that tumor perfusion measurements can be predictive of response to therapy. Patients with localized or locally advanced head and neck cancer, who are to receive concurrent chemo-radiation therapy, will receive the investigational 62Cu-ETS radiopharmaceutical for "whole-body" PET/CT imaging to assess tumor perfusion. The 62Cu-ETS imaging will occur immediately prior to scheduled standard baseline and post-therapy clinical PET/CT with 18F-FDG. A subset of patients will also be imaged using 15O-water to provide an independent reference measure of tumor perfusion. The 62Cu-ETS tumor perfusion results will be quantified using an image-derived arterial input function. Global and regional measures of tumor perfusion will be compared to the findings from 18F- FDG imaging, as well as to changes in tumor size using RECIST criteria. Subjects will be seen for follow-up one month after completion of treatment; then a minimum of every three months. The imaging results will be examined for correlations with independent measures of clinical outcome, including twenty-four month actuarial local progression-free survival, regional progression-free survival, distant metastases-free survival and overall survival. Therapy failure will be defined as biopsy-proven recurrent disease, or imaging results inconsistent with any other explanation than disease recurrence or metastases. Planned neck dissection following chemo-radiotherapy showing the presence of residual viable tumor cells will not be classified as regional failure, as this will be considered completion of the planned curative therapy. The project both requires, and exploits, radiopharmaceutical production technologies under development by Proportional Technologies, Inc., and the expertise of academic collaborators from the Purdue University School of Pharmacy and the Indiana University School of Medicine. PUBLIC HEALTH RELEVANCE: Head and neck cancers account for about 3% of adult malignancies in the United States, and disproportionately affect African Americans. This project initiates clinical evaluation of a PET imaging method to evaluate tumor blood flow, using imaging technology that can be readily implemented at medical centers throughout the country. This PET method is expected to improve the physician's ability to make optimal treatment decisions for head and neck cancer patients.